Abstract

Importance: Tenecteplase use is more prevalent as the thrombolytic drug of choice for acute ischemic stroke, with results demonstrating its non-inferiority compared to alteplase. However, there is conflicting data regarding intracranial hemorrhage risk. Objective: To determine the rate of symptomatic intracranial hemorrhage in ischemic stroke patients after thrombolysis with either tenecteplase or alteplase. Design: Retrospective cohort study. Setting: 15 Texas stroke centers. Participants: 431 patients that were eligible for thrombolytic therapy, and received either tenecteplase or alteplase. Exposure: Data was collected 90 days before and after the stroke center changed from alteplase to tenecteplase. Main Outcomes: Primary endpoint was to compare the incidence of sICH according to SITS-MOST/ECASS-3 criteria in the alteplase and tenecteplase groups. Secondary endpoint included the radiographic pattern of hemorrhagic conversion according to the Heidelberg bleeding classification (HBC). Results: Median age was 62.94 for alteplase and 64.45 for tenecteplase, females represented half of each cohort:110 for alteplase and 117 for tenecteplase. Half of patients received alteplase (n=216), 174 (81%) received alteplase within 3 hours versus 176 (82%) for tenecteplase. Endovascular thrombectomy was attempted in 34 patients (15%) receiving alteplase versus 26 patients (12%) receiving tenecteplase. 7 patients in the alteplase group (3.2%) and 14 (6.5%) in the tenecteplase group had sICH, with an odds ratio of 1.44 (95% CI 0.60-3.43; P=0.41). A higher NIHSS score on arrival (1.06; 95% CI 1.0004-1.131; P=0.04) was a statistically significant predictor of sICH. A two-sample proportion test on tenecteplase produced a statistically significant increase in HBC class 3 (P=0.040) over alteplase. Conclusions and Relevance: An increased rate of sICH was observed with a statistically significant increase in HBC class 3 with tenecteplase administration compared to alteplase. Suggested mechanisms of bleeding are hemorrhagic conversion in clinically silent infarcts and contusions underlying the lesions. This suggests a potential need to reevaluate the criteria for tenecteplase administration. Larger studies are required to confirm this data.

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